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Medicine composition-compound digestive enzyme capsule (II) and preparation method thereof

A compound digestive enzyme capsule and capsule technology, which is applied in the field of biomedicine, can solve the problems of affecting the use efficiency of pepsin, pepsin cannot be released quickly, and is damaged, so as to facilitate application, storage and transportation, save preparation costs, and simplify the process Effect

Active Publication Date: 2013-11-27
浙江华润三九众益制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

For example, Chinese patent 200710177613 discloses compound digestive enzyme capsules, but wherein pepsin and pancreatin are present in the capsule in the form of gastric-coated tablets and enteric-coated tablets respectively, the former is to maintain the stability of pepsin, But in this way, if it is chewed and taken, the enteric-coated tablet will be destroyed and the pancreatin in it will be destroyed. If it is swallowed, the pepsin cannot be released into the gastric juice quickly due to the barrier of the gastric-coated superimposed capsule, and even May enter the alkaline intestinal tract and affect the efficiency of pepsin use

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Example 1 Preparation of trypsin

[0034] We have designed the optimal expression sequence of the trypsin gene of the present invention in yeast, its nucleotide is shown in SEQ ID NO: 1, and the amino acid sequence of the trypsin encoded by it is shown in SEQ ID NO: 2. We commissioned Shanghai Shenggong Company to artificially synthesize the gene sequence and clone it into yeast cells according to conventional methods to construct expression engineering bacteria. In short, using the synthesized gene sequence as a template, using the The upstream and downstream primers were amplified by PCR, and then connected between EcoR I and Xba I of pPICZαA (available from Invitrogen, USA), and the positive construct was electrotransformed into yeast GS115 strain (available from Invitrogen, USA), and screened with Zeocin The positive yeast cells were used as engineering bacteria.

[0035] Inoculate the constructed engineered bacteria into 25ml seed culture medium (formulation: 2% ...

Embodiment 2

[0037] Example 2 Study on properties of trypsin

[0038] The trypsin prepared in Example 1 was dissolved in pH 8.0 Tris-HCl buffer solution containing 20 mM calcium chloride, put into a dialysis bag, and dialyzed twice in pH 8.0 Tris-HCl buffer solution (0.1M) at 4°C. Each time, 15 minutes each time, then adding Tos-Gly-Pro-Arg-4-pNA (Chromozym TRY) as a substrate, autoactivating trypsin at different temperatures for 1 hour, and then detecting its activity. The results are shown in Table 1. The trypsin of the present invention has high self-activation at physiological temperature, but almost no activity at low temperature, and the enzyme activity at 37°C can reach more than 300U / mg in a short time.

[0039] Table 1 Properties of pancreatin of the present invention

[0040] temperature (°C) 4 25 37 50 Activity (U / mg) 2.8 276 311 65

Embodiment 3

[0041] The preparation of embodiment 3 trypsin enteric-coated granules

[0042] (1) Dissolve hydroxypropylmethylcellulose in water, then add 95% ethanol solution to prepare 2% (W / W) hydroxypropylmethylcellulose in ethanol aqueous solution (ethanol: water (volume ratio) = 1: 1).

[0043] (2) Mix 28 parts of pancreatin, 8 parts of sucrose and 4 parts of dextrin prepared in Example 1 and put them in a centrifugal granulator (available from Shandong Linyi Huanshi Micropill Equipment Co., Ltd., BZL-300 type) According to the manufacturer's instructions, spray 32 parts of the ethanol aqueous solution of hydroxypropyl methylcellulose in step (1) (it has been measured that about 0.6 parts of hydroxypropylmethylcellulose is bound to the core of the pellet), and granulate to form The ball core, after drying, has an average particle size of 0.9mm and is ready for use.

[0044] (3) Add 3 parts of triethyl citrate to 500 parts of distilled water, mix well and then transfer into ...

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Abstract

The invention provides a medicine composition-compound digestive enzyme capsule (II) and preparation method thereof. Pepsin granule consists of pepsin, cane sugar, dextrin and hydroxypropyl methyl cellulose; pancreatin enteric coated granule consists of a pill core and coating which coats the pill core, wherein the pill core consists of pancreatin, cane sugar, dextrin and hydroxypropyl methyl cellulose and the coating consists of polyacrylic resin, triethyl citrate and talcum powder.

Description

Technical field [0001] The invention is a biomedical technology field. Specifically, the invention involves a compound digestive enzyme capsule (II).In addition, the present invention also involves the preparation methods of the above products and its middle body. Background technique [0002] Compound digestive enzyme preparations can include enzymes that work in different parts of the digestive tract, such as gastric protease and pancreatase, and also hope that they are released in different parts of the digestive tract.For example, China Patent 200710177613 disclosed compound digestive enzyme capsules. However, gastric proteases and pancreatases are in the form of gastrointestinal coats and enteric -soluble bags. The former is to maintain the stability of gastric protease.But in this way, if you chew, the enteric -soluble bag will be destroyed and the pancreatase is destroyed. If you swallow, the gastric protease will not be released into the gastric juice quickly due to the b...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/48A61K38/43A61K47/38A61K9/48A61K9/16A61P1/00A61P1/14
Inventor 朱菊红金鑫杨战涛丁莉梅傅姗瑚
Owner 浙江华润三九众益制药有限公司
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